ClinicalTrials.gov
ClinicalTrials.gov Menu

Lipids, Inflammation, and CV Risk in RA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02714881
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Katherine P Liao, Brigham and Women's Hospital

Brief Summary:
The objective of this study is to elucidate the relationship between inflammation and lipoprotein atherogenicity, and to determine the relative contribution of inflammation and lipids to CV risk in RA. The central hypothesis of this study is that inflammation and lipoprotein atherogenicity is tightly linked such that both factors are important to assess CV risk in RA. Further, the investigators hypothesize that this relationship is obscured by a consideration of routine lipids alone.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Cardiovascular Disease Drug: certolizumab Radiation: Stress myocardial perfusion PET Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis
Study Start Date : April 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Tumor necrosis factor inhibitor
Subjects who are about to start on a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. They will have measurements including routine lipids, advanced lipoproteins, and coronary flow reserve (CFR) before and after their TNFi.
Drug: certolizumab
Subjects who are about to start TNFi therapy as part of usual therapy will be enrolled. In this study we will provide the drug, certolizumab.
Other Name: Cimzia

Radiation: Stress myocardial perfusion PET
We will measure coronary flow reserve (CFR) using cardiac PET before the patients starts TNFi and 24 weeks after starting TNFi.
Other Name: Cardiac PET




Primary Outcome Measures :
  1. coronary flow reserve (CFR) measured by cardiac PET [ Time Frame: 24 weeks ]
    The investigators will compare the CFR of subjects before baseline with their CFR after 24 weeks on TNFi. Each subject serves as their own control.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RA diagnosed by a rheumatologist
  • Fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria for RA
  • Age>35
  • Active RA as defined by treating rheumatologist
  • Biologic DMARD naive

Exclusion Criteria:

  • Patients on statin or PCSK9 inhibitor therapy
  • Corticosteroid therapy >10mg prednisone or its equivalent as a maintenance treatment
  • Pregnancy
  • Unstable angina (chest pain) or shortness of breath
  • Severe valvular heart disease
  • Myocarditis
  • Pericarditis
  • Asthma with active wheezing
  • Cancer treatment within the last 5 years
  • Active infectious disease (HIV, Tuberculosis, or Hepatitis B/C)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714881


Contacts
Contact: Katherine P Liao, MD, MPH 617-525-8819 kliao@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital

Additional Information:
Responsible Party: Katherine P Liao, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02714881     History of Changes
Other Study ID Numbers: 2016P000219
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Cardiovascular Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents